The FDA mandated unit dose packaging for iron supplements in 1997 as a response to alarming numbers of iron poisoning and deaths in children less than 6 due to unintentional ingestion of toxic levels of iron. A study published in the June issue of the Archives of Pediatric and Adolescent Medicine documented the results of the FDA mandated on incidence of poisoning and deaths.
Data were gathered and analyzed from 10 years prior to the mandate and 5 years post-mandate. Before the mandated unit dose packaging of iron, incidence of poisoning was 2.9 per 1000, after the regulation change the incidence decreased to 1.9 per 1000 annually. The number of deaths decreased from 29 per year on average to 1.
These results represent significant positive effect that the mandate had on the ingestion of potentially poisonous substances by children under the age of 6. From a public health standpoint it may be efficacious to enact similar mandates on other potentially harmful substances that are a common cause of poisoning and death in children.
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